ATENOLOL

Product NDC
61919-279
Requested package NDC
61919-279-30
11-digit product format
619190279
Labeler code
61919
Product ID
61919-279_b1926c63-b001-e7b9-e053-2a95a90ac8ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATENOLOL
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA074056
Marketing category
ANDA
Marketing start
2019-09-17
Marketing end
0000-00-00
Substance
ATENOLOL
Active strength
25 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage61919-27961919-279-30IInactivated by FDA2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074056-001ATENOLOLATENOLOL50MGTABLET / ORALAB1995-01-18
A074056-002ATENOLOLATENOLOL100MGTABLET / ORALAB1995-01-18
A074056-003ATENOLOLATENOLOL25MGTABLET / ORALAB2004-07-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A074056-001AB
A074056-002AB
A074056-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-188072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A074056-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074056-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074056-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074056-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074056-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074056-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074056-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074056-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074056-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074056-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074056-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074056-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074056-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074056-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074056-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074056-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074056-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074056-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074056-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074056-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074056-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074056-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074056-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074056-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074056-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074056-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074056-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074056-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074056-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074056-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074056-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074056-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074056-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074056-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074056-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074056-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074056-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074056-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074056-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074056-001AB18072bd15b7f6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
faf41ef3-b4b3-a29e-3b26-07c3009003bfProduct name520220517
5eb1a708-d713-e905-0a08-b103c64796f4Product name320201019

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-279-902024-01-30C16284748780-1ba0f9c33-4ef2-a910-e053-dadaa90a0b85ATENOLOL
61919-279-902021-01-29C16284748780-1ba0f9c33-4ef2-a910-e053-dadaa90a0b85ATENOLOL
61919-279-602020-01-31C16284748780-19d75b9d0-4e58-f424-e053-dadaa90a57ceATENOLOL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-279-90ATENOLOL90 in 1 BOTTLETABLET905
61919-279-30ATENOLOL30 in 1 BOTTLETABLET304
61919-279-60ATENOLOL60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-279-30EA - Each61919-279f35df2a8-2281-4435-bc0f-d07c4861b99c12019-10-07
61919-279-60EA - Each61919-279b5d95c89-c3b3-4564-ba04-aca491a78abe12019-09-05
61919-279-90EA - Each61919-2790a665882-63df-4c0a-9ff4-7dbf68e2e1f912019-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL TABLET [DIRECT RX]1
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL TABLET [DIRECTRX]1
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL TABLET [DIRECT RX]1
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL TABLET [DIRECTRX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATENOLOL TABLET [DIRECTRX]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATENOLOL TABLET [DIRECT RX]1
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NAATENOLOL TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL TABLET [DIRECTRX]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XATENOLOL TABLET [DIRECTRX]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JATENOLOL TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATENOLOL TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATENOLOL TABLET [DIRECTRX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJATENOLOL TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-279ATENOLOL TABLET [DIRECT RX]5Legacy NDC, 1 package rows20190430_b002421f-8120-4e76-a9e2-cc356fbc4cff.zip
61919-279ATENOLOL TABLET [DIRECT_RX]4Legacy NDC, 1 package rows20240110_92bfe147-f86a-d0d2-e053-2a95a90a306f.zip
61919-279ATENOLOL TABLET [DIRECTRX]1Legacy NDC, 1 package rows20151030_de7fdcec-f3be-4070-acad-727d3d9894ad.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AtenololATENOLOLQPharma, Inc.70d7a585-7a46-4eac-b2b5-2ac5b98d98822025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
AtenololATENOLOLPD-Rx Pharmaceuticals, Inc.95761173-1c95-46b2-a08f-fbc3e70daba82025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
AtenololATENOLOLPD-Rx Pharmaceuticals, Inc.c69b8e5e-c7c3-4883-9cea-f7f435a8ede82025-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
AtenololATENOLOLAphena Pharma Solutions - Tennessee, LLC23e96396-85d3-0d8e-e063-6394a90a614d2024-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
AtenololATENOLOLAphena Pharma Solutions - Tennessee, LLC247569d6-9a73-f1d0-e063-6394a90a667a2024-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
AtenololATENOLOLNuCare Pharmaceuticals,Inc.7366c6f8-4cb3-520e-e053-2991aa0a2cc82024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
AtenololATENOLOLTeva Pharmaceuticals USA, Inc.25a72ec9-de0f-44e5-90b8-da1aab0d35882024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
AtenololATENOLOLA-S Medication Solutionsd73a475a-c8c9-44a0-89ac-6a2d665c0d242023-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
AtenololATENOLOLProficient Rx LP24f1f3f4-bbda-458b-b15f-d942c90534e22022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
AtenololATENOLOLBryant Ranch Prepackba0b0221-d4b3-4cb1-9435-53a75fcc4b402020-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
AtenololATENOLOLProficient Rx LPb198b34c-861a-4b52-b4df-8c48b807520a2020-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197379atenolol 100 MG Oral TabletPSNb002421f-8120-4e76-a9e2-cc356fbc4cff5
197380atenolol 25 MG Oral TabletPSNb002421f-8120-4e76-a9e2-cc356fbc4cff5
197379atenolol 100 MG Oral TabletSCDb002421f-8120-4e76-a9e2-cc356fbc4cff5
197380atenolol 25 MG Oral TabletSCDb002421f-8120-4e76-a9e2-cc356fbc4cff5
197380atenolol 25 MG Oral TabletPSN92bfe147-f86a-d0d2-e053-2a95a90a306f4
197380atenolol 25 MG Oral TabletSCD92bfe147-f86a-d0d2-e053-2a95a90a306f4
197380atenolol 25 MG Oral TabletPSNde7fdcec-f3be-4070-acad-727d3d9894ad1
197380atenolol 25 MG Oral TabletSCDde7fdcec-f3be-4070-acad-727d3d9894ad1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-279-306191902793030 TABLET in 1 BOTTLE (61919-279-30) 30 tablet2019-09-170000-00-00NoNoCurrent